Regulatory Focus™ > News Articles > EMA Releases Revised Draft Guideline on Pediatric Regulation

EMA Releases Revised Draft Guideline on Pediatric Regulation

Posted 04 January 2013 | By Alexander Gaffney, RAC

The European Medicines Agency (EMA) has released a newly-revised draft guideline regarding the development of pharmaceutical products intended for use in children, taking into account comments received on a draft version released in 2011.

The changes made to the initial draft guideline, Guideline on pharmaceutical development of medicines for paediatric use, were reportedly significant enough for EMA to partially restart the comment period on the guideline, which is now open through 31 March 2013.

The guideline aims to clarify some of the requirements surrounding the EU "Pediatric Regulation," which is intended to guide the development of pediatric medicines. The overarching objective of the Pediatric Regulation, observes EMA, is to make sure medicinal products are effective through highly targeted clinical trials, while at the same time ensuring that trial subjects are not subject to a product with a negative risk-benefit assessment.

Unlike the original consultation period, EMA said it will only consider three sections of the guideline for comment: Section 6.2.1 (Handling of oral solid preparations to facilitate administration), Section 10 (Mixing with food) and a section on patient acceptability.

EMA explained that these sections have experienced changes as the result of comments. Section 6.2.1., for example, is significantly revised and expanded, with considerable additional detail given to the use of tablets, capsules, chewable preparations and alternate dosing strategies such as crushing, liquid dispersion and the use of food. If food or drink items are used to facilitate treatment, EMA noted that sponsors will need to ensure that a variety of factors are controlled, including the temperature of the food products, the portion size, the time of consumption after which the products are combined, and any potential effects of the food product on the medicinal product being studied.

Finally, EMA has worked these concepts into a revised section on "patient acceptability," which now links up the attributes of a treatment regimen-palatability, swallowability, complexity of handling, required dose and dose frequency, route of administration, etc.-with whether or not a patient should be considered for a clinical trial. A mismatch between a patient and a product is more likely to cause a patient to drop out of the trial or not properly adhere to a treatment regimen, EMA noted.

The section also delves deeper into the issue of palatability, which EMA now notes is something of a requirement rather than an aspiration. "Unless otherwise justified, the palatability of a paediatric medicine should be satisfactory on its own merit (i.e. without mixing with food or drinks)," it wrote. Product sponsors should therefore take into account the excipients, flavoring agents, particle size, coating, or complexing agents used in an oral solid-dose medication. Similar measures should be taken for oral liquid-dose drugs as well, EMA explained.

Comments on the draft guidance should be sent to by 31 March 2013.


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.